Perineal tears causes much discomfort among women post partum, but even long term ailments can occur. Lacerations involving the anal sphincter function and anal canal are looked upon as more serious than the ones involving the mucosa and perineal body only, however all kinds of rupture give discomfort. The more extensive the rupture, the more troublesome are the complaints afterwards. Especially ruptures involving the anal sphincter muscles have been studied, since the frequency have increased the last two decades from 0.6% to approximately 4 to 8% varying between different obstetric departments. The long-term results of women with earlier anal sphincter ruptures having unfortunately shown that many are still suffering of anal sphincter incompetence. 50% of these women have persisting complaints with gas incontinence but also incontinence of liquid stool and in worst cases even formed stool. The reasons for this are many, but one is that the medium weight of the newborns has increased from 3.3 kg to 3.6 kg during the last 20 years. We know that baby weight and tears are related. It is therefore imperative to reduce the number of tears and give the perineum some protection especially with the future problems of increased baby weight in mind.
WO 2007/131109 A2 discloses a perianal support device that is configured to inhibit the formation and/or progression of tissue damage in the perianal region of the body. WO 2007/131109 A2 also discloses a method to apply the perianal support device to patients during childbirth to inhibit the formation and/or progression of tissue damage in the perianal region of the body. The device disclosed in WO 2007/131109 A2 comprises a construction having a rigid part (330, 340) intended to be in connection with the perianal region. Thus, the tissue in contact with the device is formed in accordance with the device by the pressure applied by the device. A further problem with the device of W0 2007/131109 A2 is that it does not reduce the risk of tissue ruptures originating from the posterior vaginal area, such as the lowest portion 9 of the vaginal opening, as it only protects the perianal area close to the anal sphincter. Moreover, the rigidness of the device provides for poor force distribution of the forces that arises during child delivery in the perineal area.
Delivery of the foetal head is when it passes through the introitus, i.e. the opening of the vagina. During this process minor or major spontaneous lacerations often occur, giving rise to postpartum discomfort and even long term effects as anal incontinence. The location of the rupture is usually located at the edge between the posterior wall of the vagina and the perineum (the skin between the vagina and rectum) the so-called commissura posterior. These ruptures can be classified in 4 different levels depending on the extension of the tear, where I is superficial and 4IV is an extensive tear into the rectum. When the rectum is involved the anal sphincter is usually injured as well.
Hence, an improved device, and method would be advantageous providing for reduced tissue damage of the mother during childbirth.